BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 3862936 · Received February 20, 2014

    Report

    Report Number
    3006556115-2014-00055
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    February 3, 2014
    Report Date
    January 30, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY EXPERIENCING INTERMITTENCIES, SOUND QUALITY ISSUES, AND POOR PERFORMANCE. PROGRAMMING CHANGES WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106873 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR